Workshops: Clinical Trials - changes
We participated in virtual workshops: "Clinical Trials - changes in submission and approval process. Quality Management during COVID-19" organised by Media Biznes.
Pending the entry into force of Regulation 536/14, either Sponsors, CROs or Clinical Sites are preparing to introduce the new guidelines. New rules will take effect soon.
The ongoing COVID-19 pandemic is having a huge impact on both the management and the process of clinical trials. The new approach to quality complies with the guidelines of the relevant authorities, so as to ensure maximum safety for study subjects.